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Monoclonal Antibodies

Tozorakimab for COPD (PROSPERO Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 104 weeks.
Awards & highlights

PROSPERO Trial Summary

This trial studies safety & effectiveness of a new COPD treatment. Subjects may be offered a chance to join an extension study.

Who is the study for?
This trial is for adults with symptomatic COPD who've completed the OBERON or TITANIA studies without early discontinuation. They must have taken their last dose within 12 weeks and agree to continue using contraception. Excluded are those with significant health issues, involvement in study planning, inability to follow study requirements, known allergies to trial drugs, or use of certain immunosuppressives.Check my eligibility
What is being tested?
The trial tests Tozorakimab's long-term safety and effectiveness against a placebo in managing COPD symptoms. It's a phase 3 extension from previous studies (OBERON/TITANIA), maintaining a double-blind approach where neither participants nor researchers know who receives the actual drug versus placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, monoclonal antibodies like Tozorakimab can cause allergic reactions, infusion-related discomforts, immune system changes leading to increased infection risk or inflammation of organs.

PROSPERO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 104 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first severe COPD exacerbation in former smokers.
Secondary outcome measures
Annualised rate of moderate to severe COPD exacerbations.
Annualised rate of severe COPD exacerbations.
Incidence of anti-drug antibodies.
+4 more

PROSPERO Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tozorakimab Dose 2Experimental Treatment1 Intervention
Injection subcutaneously Tozorakimab via pre-filled syringe.
Group II: Tozorakimab Dose 1Experimental Treatment1 Intervention
Injection subcutaneously Tozorakimab via pre-filled syringe.
Group III: PlaceboPlacebo Group1 Intervention
Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,618,454 Total Patients Enrolled

Media Library

Tozorakimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05742802 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: Tozorakimab Dose 1, Tozorakimab Dose 2, Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Tozorakimab Highlights & Side Effects. Trial Name: NCT05742802 — Phase 3
Tozorakimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05742802 — Phase 3
~741 spots leftby Jul 2025
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